Definitions.

As used in this subpart: (a) Acne. A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes. (b) Acne blemish. A flaw in the skin resulting from acne. (c) Acne drug product. A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads. (d) Acne pimple. A small, prominent, inflamed elevation of the skin resulting from acne. (e) Blackhead. A condition of the skin that occurs in acne and is characterized by a black tip. (f) Whitehead. A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin.